Here’s the Monday Morning Recap (once again on Tuesday, we really should change the name), the weekly post where we call out recent drug and device law and policy developments that caught our eye and made us think.

1. Last week, as reported by Reuters, outgoing Food and Drug Administration Commissioner Margaret Hamburg gave her final speech, in which she “defended the agency’s drug approval standards against critics seeking weaker regulatory standards.” Commissioner Hamburg “noted that the FDA typically approves new drugs faster than any other developed nation,” and said “‘In the race for the newest treatment we must remember the point that innovation doesn’t matter if the product doesn’t work[.]'”

2. At Chemical & Engineering News, Bethany Halford offered a helpful explainer about PCSK9 inhibitors, a new class of anti-cholesterol biologics. The FDA is expected to approve two such inhibitors, one developed by Amgen and one by Sanofi and Regeneron, for marketing this summer. Halford writes:

“Determining what insurance companies are willing to pay for PCSK9 inhibitors is where [analyst Victoria Hudson] sees the biggest challenge. Currently, a lot of patients are taking inexpensive statins. Because making a biologic is technologically taxing and therefore much more expensive than making a small molecule, she notes, the entire investment structure for these patients is going to change. Expensive biologics certainly aren’t new, Hudson says, ‘but I don’t think there’s ever been a market where there’s such high potential for their usage.'”

3. At Pharmalot yesterday, Ed Silverman reported that “[t]he American Pharmacists Association, the leading organization representing pharmacists in the U.S., has voted to discourage its approximately 62,000 members from providing medications for executions, marking the second time in a week that a pharmacists’ group has taken such a step. Last week, the International Academy of Compounding Pharmacists adopted a similar policy.” This brings the APA and the IACP “in line with policies held by the American Medical Association, the American Nurses Association and the American Board of Anesthesiology.”

4. Also at Pharmalot, Ed Silverman commented on the release of a long-awaited report issued “in response to ongoing questions about the 2004 suicide of a troubled 26-year old man named Dan Markingson” who participated in a clinical trial at the University of Minnesota “that was designed to examine the effectiveness of three different antipsychotic pills and that had been funded by AstraZeneca.” The report “which was released by the state legislative auditor – finds the university’s handling of the episode raised serious issues that have damaged its ‘credibility and reputation.’”

5. Finally, I highly recommend this, a gripping cliffhanger about “how one of the nation’s best hospitals—US News & World Report regularly ranks UCSF among the top 10 — could give a patient a 39-fold overdose of a common antibioti[.]”